J.D., President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries.
His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc.
Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally.
He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.
Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University.
Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.